Characterization of Focal Liver Lesions by Real-Time Contrast-Enhanced Ultrasound Imaging (CEUS)

Liver Cancer Clinical Trial

Official title:

Characterization of Focal Liver Lesions by Real-Time Contrast-Enhanced Ultrasound Imaging (CEUS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243633
• Other study ID #: CIT 05 - FT / ECUS
• Status: Completed
• Phase: N/A
• First received: October 21, 2005
• Last updated: March 18, 2008
• Start date: April 2005
• Est. completion date: August 2007

Study information

• Verified date: March 2008
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The conventional sonography is frequently used to detect incidental focal liver lesions because of its availability, innocuity and low cost. Nevertheless, sensibility and specificity of conventional sonography does not exceed 70% for tumoral affections. Consequently the interest of this practice must be reconsidered by studying its ratio cost/diagnosis contribution.

These limitations of conventional sonography have led to the use of other imaging modalities and invasive or costly procedures such as computed tomography (CT), magnetic resonance imaging (MRI) or biopsy. The availability of real-time contrast-enhanced ultrasound imaging (CEUS) has changed the strategy in the characterization of focal liver lesions, on healthy or cirrhotic liver in a neoplastic context or not, without inconvenience for the patient.

The aim of the present study is to evaluate the place of CEUS in term of diagnostic relevance and catch of load cost, in the characterization of focal liver lesions detected but not characterized by CT or conventional sonography.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 878
• Est. completion date: August 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Target focal liver lesion of size lower than 10 cm and higher than 5 mm detected by conventional ultrasonography

Exclusion Criteria:

• Patients with acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: myocardial infarction, recent coronary artery intervention, acute cardiac failure (within last month), acute endocarditis and prosthetic valves.

• Pregnant and lactating women

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Focal Liver Lesions
• Liver Cancer
• Liver Cirrhosis

Intervention

Procedure:
• Real-time contrast-enhanced ultrasound sonography

Locations

Country	Name	City	State
France	CHRU d'ANGERS	Angers
France	Hôpital Saint-Jacques, CHRU Besancon	Besançon
France	Hôpital Saint-André, CHRU Bordeaux	Bordeaux
France	Hôpital Beaujon, Assistance Publique Hôpitaux de Paris	Clichy
France	Hospices Civils de Lyon	Lyon
France	Hôpital Saint-Eloi, CHRU Montpellier	Montpellier
France	Hôpital Necker, Assistance Publique Hôpitaux de Paris	Paris
France	Hôpital Pitié Salpétrière, Assistance Publique Hôpitaux de Paris	Paris
France	Hôpital La Milétrie, CHRU Poitiers	Poitiers
France	Hôpital Robert Debré, CHRU Reims	Reims
France	Hôpital Nord, CHRU Saint-Etienne	Saint-Etienne
France	Hôpital Bretonneau, CHRU Tours	Tours
France	Service de Radiologie, Hôpital d'Enfants de Brabois	Vandoeuvre les Nancy
France	Hôpital Paul Brousse, Assistance Publique Hôpitaux de Paris	Villejuif
France	Institut Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Tours	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (7)

Albrecht T, Blomley MJ, Burns PN, Wilson S, Harvey CJ, Leen E, Claudon M, Calliada F, Correas JM, LaFortune M, Campani R, Hoffmann CW, Cosgrove DO, LeFevre F. Improved detection of hepatic metastases with pulse-inversion US during the liver-specific phase of SHU 508A: multicenter study. Radiology. 2003 May;227(2):361-70. Epub 2003 Mar 20. — View Citation

Basilico R, Blomley MJ, Harvey CJ, Filippone A, Heckemann RA, Eckersley RJ, Cosgrove DO. Which continuous US scanning mode is optimal for the detection of vascularity in liver lesions when enhanced with a second generation contrast agent? Eur J Radiol. 2002 Mar;41(3):184-91. — View Citation

Bernatik T, Becker D, Neureiter D, Hänsler J, Frieser M, Schaber S, Hahn EG, Strobel D. [Detection of liver metastases--comparison of contrast--enhanced ultrasound using first versus second generation contrast agents]. Ultraschall Med. 2003 Jun;24(3):175-9. German. — View Citation

Kim TK, Choi BI, Hong HS, Choi BY, Han JK. Improved imaging of hepatic metastases with delayed pulse inversion harmonic imaging using a contrast agent SH U 508A: preliminary study. Ultrasound Med Biol. 2000 Nov;26(9):1439-44. — View Citation

Leen E, Angerson WJ, Yarmenitis S, Bongartz G, Blomley M, Del Maschio A, Summaria V, Maresca G, Pezzoli C, Llull JB. Multi-centre clinical study evaluating the efficacy of SonoVue (BR1), a new ultrasound contrast agent in Doppler investigation of focal hepatic lesions. Eur J Radiol. 2002 Mar;41(3):200-6. — View Citation

Quaia E, Bertolotto M, Forgács B, Rimondini A, Locatelli M, Mucelli RP. Detection of liver metastases by pulse inversion harmonic imaging during Levovist late phase: comparison with conventional ultrasound and helical CT in 160 patients. Eur Radiol. 2003 Mar;13(3):475-83. Epub 2002 Sep 26. — View Citation

Tranquart F, Bleuzen A, Tchuenbou J. [Contrast ultrasound imaging in focal liver lesions: diagnostic value and guidelines]. J Radiol. 2004 May;85(5 Pt 2):680-9. Review. French. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical and economic interest of CEUS
Secondary	Method acceptability
Secondary	Contrast-enhanced ultrasound sonography tolerance
Secondary	Harmony inter-readers